Let Me Be Direct: A-5513 Coding Clarification & The Future of CAD/CAM Direct-milled Inserts

The Situation The Durable Medical Equipment Medicare Administrative Contractors (DME MACs) issued a joint publication on July 13 that addressed the proper use of diabetic shoe insert Healthcare Common Procedure Coding System (HCPCS) code A-5513 (for diabetics only, multiple density insert, custom molded from model of patient's foot, total contact with patient's foot, including arch, base layer minimum of 3/16-inch material of shore [a 35 durometer or higher], includes arch filler and other shaping material, custom fabricated, each).

According to the publication, diabetic inserts billed using A-5513 must be molded over an actual model of the patient's foot. The use of a virtual, generic, or electronic model in custom fabrication without creating a physical model of the patient's foot does not meet the code descriptor. Since this clarification precludes using CAD/CAM direct milling of the custom insert from a digital positive, which increases efficiency and cost-effectiveness, The O&P EDGE asked experts what this clarification may mean for your business. Who Will Be Affected? The impact on orthotists and pedorthists who provide the inserts to their patients would not appear to be great, says Joe McTernan, director of coding and reimbursement services, education, and programming, American Orthotic & Prosthetic Association (AOPA). "I would say the majority of folks that are fabricating these inserts in their lab, in their own O&P facility, are likely using the traditional methods of casting, and creating a positive model. Where this is going to have an impact is on the manufacturers; they're the ones who have the money and the infrastructure invested in these higher technology systems."

Jeremy Janisse , CPed, COA, senior manager lab operations, Dr. Comfort, Mequon, Wisconsin, says Dr. Comfort is still in the early stages of evaluating ways of changing their process, and the impact of the clarification on their business. "I see it going one of two ways," he predicts. "If shortcuts are taken, the new process is either going to increase the cost or decrease the quality of product to the practitioner. With Medicare's firm reimbursement rate, some practitioners are probably going to get out of the game because there's not enough [profit] margin. Ultimately, the people that I would be most concerned with it affecting is the patient, who potentially may not have a quality product—or any product available." Why Is CMS Doing This? Is the Centers for Medicare & Medicaid Services taking this clarification action to save money, as some believe?

"CMS is always looking to cut costs," McTernan concedes, "but I don't know that this change would represent enough of a cost saving to be the genesis for the change." Initially, he says, AOPA looked at data from the American Diabetes Association (ADA) that shows the Medicare output for the cost of custom-molded inserts under A-5513 to be less than 1 percent of the overall expenditure on diabetic care in 2012, which makes a potential cost saving in that area "truly minimal." McTernan says he believes the coding clarification was more likely motivated by a question that arose during the normal Pricing, Data Analysis and Coding (PDAC) code verification process, and snowballed into a much larger issue. "During the process it was determined, through one or more submissions from manufacturers, that they were using a direct-milled process and were not creating a physical model of the patient's foot. And in discussing that code verification application with those manufacturers, the question was raised as to whether inserts that were manufactured this way met the strict definition of the code verbiage for A-5513—which obviously they determined that it did not. "This seems to be an awful big brouhaha over not a lot of potential savings. And, if you're looking to cut costs, this is not the way to do it," McTernan adds. What Must Manufacturers Do? According to McTernan, PDAC recently announced that all products verified for A-5513 as of July 2017 will have to go through the process again.

Brian Lane, director of education, Dr. Comfort, states that they are still considering their options internally while preparing new PDAC submissions for the required change. "We are looking at old processes and reviewing updates to our current process and software. Our goal is to try and make sure that if there is an option of doing a milled orthotic that we are prepared, because I think that's probably what it's going to take to convince Medicare that this is as good a product—if not better—than a molded orthotic." Techniques Defined, Compliance Explained Direct-milled diabetic insert : The supplier sends either the patient's scan or foam box to the manufacturer's lab, who uses software to produce a digital image of the foot. The image is rectified in the software according to the prescription before the image is sent to a CNC router machine and the inserts are direct milled. This is to be billed as code A-9270 (non-covered) since it was not made from a physical positive model of the foot, according to the article published by the Durable Medical Equipment Medicare Administrative Contractors. Vacuum-pressed diabetic insert : The supplier sends a foam box to the lab. The lab pours plaster in the box to create a positive model. The model is put into a vacuum press, material is placed on the model and vacuum pressed. This is to be billed as A-5513, since it is made from a positive model of the foot, according to the published article. Joe McTernan, director of coding and reimbursement services, education, and programming, AOPA, explains what makes the difference between inserts that are A-5513- compliant or noncompliant: "Probably most folks are no longer actually using casting materials to get an image; instead, they typically use CAD/CAM scanning technology that then creates a digital image. So far, that process is completely compliant. Where it hits a roadblock is what you then do with that digital image. If you send it off to a manufacturer, and they produce a positive model of the foot based on that digital image, and they fabricate the insert to that positive model, that is compliant with the code language. "Not compliant is if [manufacturers] feed that digital image into a software program that then direct mills an insert based on that digital model or image. "It's a nuance of a difference, but it's important. As long as there's a physical 3D model of the patient's foot created—whether it's done using plaster or whether it's done using CAD/CAM— there's no issue with the code language as it currently stands. It only becomes an issue if there's no model of the patient's foot made from that scan, and it's simply direct milled based on the measurements from it." Who's Tackling This Problem—And How? Most agree that a reversal, partial reversal, or mitigating adjustment to the A-5513 coding clarification is needed. However, there is some confusion concerning where arguments, protests, and reasoned appeals should be directed.

Since the clarification was based on language used in the 1993 Medicare Therapeutic Shoe Bill, which was passed into law as an act of Congress, Janisse reports being told affected parties should appeal the clarification to their member of congress. "I wholeheartedly disagree," he says, "and feel that a change could be made in our local coverage determination [LCD] that does not require an act of Congress…." CMS did not require an act of Congress to make the coding clarification announcement official, and Dennis Janisse , CPed, president and CEO, National Pedorthic Services, headquartered in Milwaukee, says that CMS' previous adjustments to the bill's language have not required Congressional involvement—e.g., the added requirement for progress notes and documentation that must accompany reimbursement requests. Currently, several entities and organizations plan to respond by approaching CMS directly to share their concerns about the detrimental impact the A-5513 coding clarification is likely to have on patients, as well as the handicap it may impose on providers' ability to effectively serve those patients. McTernan says that the only group that has the authority to make changes to the wording of the official HCPCS code is the CMS-based HCPCS Alpha-Numeric Editorial Panel, headed by Cynthia Hake, deputy director, Division of Home Health, Hospice, and HCPCS. The panel reviews and updates coding annually, and can make a change in code language at any time during the year, he notes. "It's rare that they do, but this could go into effect as soon as January 1, 2018." He revealed that at the time of this writing, AOPA and other organizations were reviewing strategies for approaching CMS, "perhaps requesting a change to the code verbiage for that code—and others—that would essentially allow for custom fabrication without requiring a ‘molded-to-patient model'." (Editor's note: After completion of this article, AOPA and the American Podiatric Medical Association (APMA) sent a joint letter to CMS administrator Seema Verma expressing concern about the issue. See pg. 13 in Industry Review for details.) McTernan also noted that AOPA, or AOPA through its relationship with the O&P Alliance, was actively pursuing a meeting with Laurence Wilson, director, CMS, who has oversight over this issue, to determine if CMS can instruct its Durable Medical Equipment Administrative Contractors (DME MAC s) to take a less conservative interpretation of the code language. "AOPA has also established a very open dialogue with our partners and our colleagues at the American Podiatric Medical Association, which has a very vested interest in this issue as well. There will also be some outreach to the American Diabetes Association about this—most likely through the Alliance," McTernan says. A member of the American Board for Certification in Orthotics, Prosthetics and Pedorthics (ABC), Dennis Janisse is aware of other ongoing efforts to reach out to CMS for discussions. "The Alliance is taking this very seriously and has put together a committee to very aggressively address this issue. This isn't their first battle; the Alliance has real credibility in Washington, and I put a lot of stock in that. Talking Points Historical Purpose, Supporting Statistics

Randy Stevens, BOCPD, CPed, CFo, owner, Randy Stevens Family Footcare, Harrisburg, Pennsylvania, has been making his own custom orthotics in-house from plaster casts since 1989, including diabetic inserts. As past president of the Pedorthic Footcare Association, in charge of their government affairs committee, he's familiar with the caveats and loopholes that perforate most regulations.

"The whole purpose of the Therapeutic Shoe Bill and the LCD for Medicare was…to reduce lower-limb amputations. Studies show that possibly 78,000 individuals did not have amputations because of the A-5513 diabetic insert. As long as they're seeing a decrease instead of a rise in amputations, why should they decide to tamper with the verbiage?" Stevens also quotes a physician who attributed a $25,000 annual savings in hospital visits alone to the diabetic insensate patients' use of the A-5513 diabetic insert. Dennis Janisse agrees: "There's plenty of evidence out there to show that providing people with shoes and inserts decreases ulcerations and decreases amputations. A CDC [Centers for Disease Control and Prevention] study showed a 65 percent decrease in amputation rates. Medicare and Medicaid typically pay to solve the problems only after they happen; this is the only preventative benefit that Medicare offers—and it works. But now it's under attack." Stevens also points to foot ulcer research such as the May 2013 study published by Analysis Group, Denver, Colorado, and Organogenesis, Canton, Massachusetts, that focused on costs of medical care for patients with diabetic foot ulcers, as compared to patients with diabetes without foot ulcers. It found that the patients with diabetic foot ulcers were almost twice as costly—costing Medicare more than $11,000 more per patient than patients being treated for diabetes without foot ulcers. Cost-effectiveness Comparison: Molded Versus Direct Milled

A longtime in-house plaster caster himself, Stevens nonetheless recognizes that direct milling from a CAD image helps reduce costs. "When you do plaster work, from start to finish in fabrication you have maybe an hour and half in pouring, gluing, and molding time, etc. That's a lot of time that's not getting reimbursed at current labor rates. Add to that your evaluation, assessment, and measurement time—plus fitting and follow-up—and finally the liability insurance, and it's an awful lot for a little. With reimbursement costs where they are, it's very hard to do it without technology."

Stevens adds, "And how many technicians would it take just to make plaster casts and do compression molding as opposed to using a carver? Big difference." Dennis Janisse stresses the greater accuracy and truer custom fit that digital scanning provides, compared to plaster. "The use of CAD/CAM eliminates a lot of hands-on human variables that allow for differences in the rasping, sanding, grinding, and trimming processes. All those variables in the vacuum-forming process are eliminated with the appropriate software. It's better than doing it by hand, and that's why O&P has been using this kind of technology successfully for so many years; the machines don't make mistakes—we do." Does It Boil Down to Semantics?

McTernan points out that accuracy is not really the issue, however. "The sticking point, from what I understand from the DME MACS, is that the code language specifically says, ‘molded to patient model,' which is then further defined in official documents as ‘requiring a physical model of the patient's body segment or part.'"

Dennis Janisse, who was involved in developing the original text of the 1993 Therapeutic Shoe Bill, offers a simple reason for the committee's word choice. "At the time, everybody vacuum formed; that's all there was. So that's what it says—‘vacuum formed.' But PDAC knew when we applied later that we were using CAD/CAM. Some of those companies have been approved for 20 years with CAD/CAM, providing appropriate, functional, and satisfactory products—yet now, all of a sudden, they won't be able to get approved." The Snowball Effect Whatever CMS' intent in publishing the coding clarification, potential repercussions and future trends worry some experts.

Stevens expresses concern about the evolution away from CMS' former partnership with providers on behalf of patients. "It appears to me that CMS is expanding a loophole without asking any input from those concerned," he says. "Years ago, as pedorthists, podiatrists, orthotists, prosthetists, we all had input into the rule-making process, where now, there's no consulting beforehand on this language—as there should be." Like others, he worries that CMS' reluctance to allow CAD/CAM direct milling for diabetic inserts could spill over to limit CAD/CAM applications in other areas of O&P, as well—including exciting new developing fields such as 3D printing, which uses no positive model. What Can Providers Do? Call Your Congressman

Even if the bill is not likely to be readdressed by Congress, your congressman can and will use their direct conduit to CMS to investigate and express concerns on their constituents' behalf, Dennis Janisse advises. "Advising them of your fears of loss of a patient's access to the diabetic inserts they need could put pressure on CMS to address this issue."

Support the Organizations That Support You

These organizations include AOPA, the O&P Alliance, APMA, ABC, the Board of Certification/Accreditation, ADA and others interested in the outcome of upcoming discussions with CMS about the A-5513 coding issue.

Know How Your Products Are and Will Be Fabricated

If you find yourself on your own, there are two options Dennis Janisse describes. Begin fabricating in-house: "Buy an oven and a vacuum former and get started; if you're making products only for your own patients, you don't have to be approved by PDAC. But consider carefully the costs of materials, labor, overhead, and advertising before making what may not be a practical or cost-effective decision. [Or,] choose the remaining approved heat-molded method coded A-5512—less effective and accurate than a custom-made insert, and not appropriate for everyone, but doable. Making the six insoles the code requires, trimming, and finishing each one is time-consuming, however, and reimbursement is significantly less than for a custom insert."

Hope for a Favorable Resolution

"My gut says something is going to happen," adds Janisse optimistically. "I have a hunch that the manufacturers are going to come up with something. There's a lot at stake here for many of us."

Judith Philipps Otto is a freelance writer who has assisted with marketing and public relations for various clients in the O&P profession. She has been a newspaper writer and editor and has won national and international awards as a broadcast writer-producer.

Let Me Be Direct: A-5513 Coding Clarification & The Future of CAD/CAM Direct-milled Inserts

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